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Phase I Study of BAY73-4506 in Chinese Patients With Advanced, Refractory Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01096030
First received: March 29, 2010
Last updated: January 21, 2013
Last verified: January 2013
History of Changes
  Purpose

This will be an uncontrolled, open-label, non-randomized, phase I study. The primary objectives of this study are to define the pharmacokinetics (PK) and to evaluate the safety and tolerability of Regorafenib administered orally as a single agent in Chinese patients with advanced solid tumors. The secondary objectives are to evaluate tumor response of patients treated with Regorafenib.


Condition Intervention Phase
Neoplasms
 Drug: Regorafenib (Stivarga, BAY73-4506)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Uncontrolled, Open-label, Non-randomized, Phase 1 Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of BAY73-4506 in Chinese Patients With Advanced, Refractory Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer
Drug Information available for: Regorafenib
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Pharmacokinetics as measured by cmax and AUC [ Time Frame: Cycle 0, Day 1-5,Cycle 1 Day 1,8,15,21,Cycle 2 Day 1,Modified Dosing Cycle Day 21 ] [ Designated as safety issue: No ]
  • Adverse Event collection [ Time Frame: every 1-2 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Objective tumor response rate [ Time Frame: Every 8 weeks for the first 6 cycles, afterwards every 12 weeks ] [ Designated as safety issue: No ]
  • Exploratory Biomarker analysis [ Time Frame: Screening, Cycle 0 or 1 ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: July 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Regorafenib Drug: Regorafenib (Stivarga, BAY73-4506)
160 mg oral once daily BAY 73-4506 for 3 weeks of every 4 week cycle (i.e. 3 weeks on, 1 week off)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female Chinese subjects >/- 18 years
  • Advanced, histologically or cytologically confirmed solid tumors
  • Subjects malignancies must be refractory to standard treatment or have no standard therapy available, or the subject actively refused any treatment that would be regarded standard, and/or if, in the judgment of the investigator or his/her designated associate(s), experimental treatment is clinically and ethically acceptable.
  • Eastern Cooperative Oncology Group performance status (ECOG-PS) 0-1;
  • Adequate bone marrow, liver and renal function
  • Life expectancy of at least 3 months

Exclusion Criteria:

  • Unstable/uncontrolled cardiac disease
  • History of arterial or venous thrombotic or embolic events
  • Malabsorption condition
  • Severe renal impairment; persistent proteinuria >/= Grade 3
  • Symptomatic metastatic brain or meningeal tumors
  • Clinically significant bleeding >/=Grade 3 within 30 days before start of study medication.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096030

Locations
Hong Kong
Shatin, N.T, Hong Kong
Hong Kong, Hong Kong
Singapore
Singapore, Singapore, 169610
Singapore, Singapore, 119228
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT01096030     History of Changes
Other Study ID Numbers: 14996
Study First Received: March 29, 2010
Last Updated: January 21, 2013
Health Authority: Singapore: Health Sciences Authority
Hong Kong: Department of Health

Keywords provided by Bayer:
Regorafenib
Advanced
Refractory solid tumors

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013